Chemoradiotherapy for Limited Advanced Unresectable Thymic Epithelial Tumors
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|ClinicalTrials.gov Identifier: NCT02636556|
Recruitment Status : Active, not recruiting
First Posted : December 21, 2015
Last Update Posted : January 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Thymoma and Thymic Carcinoma||Radiation: concurrent chemoradiation||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Intensity modulated radiotherapy with VP-16/Cisplatin|
|Masking:||None (Open Label)|
|Official Title:||Phase Ⅱ Study of Concurrent Chemoradiotherapy for Limited Advanced Unresectable Thymic Epithelial Tumors|
|Actual Study Start Date :||June 2011|
|Actual Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||May 2020|
Radiation: concurrent chemoradiation
The patients receive chemotherapy concurrent with Radiotherapy. The prescription dose is 60Gy in 30 fractions in 6 weeks.The chemotherapy regimen is cisplatin (25mg/m2,iv drip,d1-3) and etoposide (75mg/m2,iv drip,d1-3),q4w*4.
- Objective response rate [ Time Frame: 3 months after treatment ]Evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.0 criteria
- Overall survival [ Time Frame: 2 years ]from registration to death as a result of any cause.
- Progression free survival [ Time Frame: 2 years ]from registration to first documentation of disease progression or death.
- Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v4.0 [ Time Frame: up to 2 years ]Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v4.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02636556
|Shanghai, Shanghai, China, 20032|
|Principal Investigator:||Kailiang Wu, M.D.,Ph.D||Fudan University|